Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Study ID
NCT03014687
Phase
PHASE4
Status
Recruiting
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Conditions

  • Antibiotics
  • Pituitary Adenoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    PO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
  • Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole — DRUG
    Oral antibiotics (cefdinir \[Omnicef®\] 300 mg PO BID or trimethoprim/sulfamethoxazole \[Bactrim DS™\] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.

Study Details

To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection (sinusitis), and helps mucosal healing in the nasal passages.

Key Dates

Start date
Jul 1, 2017
Status verified
Aug 2018
Primary completion
Jan 31, 2019
Completion
Jul 31, 2019

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Standard Nasal Care
    One dose of preoperative intravenous (iv) antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Postoperative antibiotics: Study participants will receive one dose only of postoperative intravenous antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg \[cephalosporin allergic patients\]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Placebo PO BID (twice daily) will commence on the morning of postoperative day 1 and continue for 7 days.
  • Experimental: Standard Nasal Care + Oral Antibiotics
    One dose of preoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg) will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Participants will receive 1 dose only of postoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg \[cephalosporin allergic patients\]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Oral antibiotics will commence on the morning of postoperative day 1; this group will receive oral antibiotics (cefdinir \[Omnicef®\] 300 mg PO BID or trimethoprim/sulfamethoxazole \[Bactrim DS™\] PO BID for cephalosporin intolerant patients) for 7 days.

Primary Outcome Measure

Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12) [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Barrow Brain and SpinePhoenixArizona85013
Heidi Jahnke, RN,MSN
[email protected]
602-406-6976
Andrew Little, MD (PRINCIPAL_INVESTIGATOR)
James Evans, MD (PRINCIPAL_INVESTIGATOR)
Varun Kshettry, MD (PRINCIPAL_INVESTIGATOR)

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